American Journal of Law & Medicine

Between a Rock and a Hard Place: Can Physicians Prescribe Opioids to Treat Pain Adequately While Avoiding Legal Sanction?

Prescription opioids are an important tool for physicians in treating pain but also carry significant risks of harm when prescribed inappropriately or misused by patients or others. Recent increases in opioid-related morbidity and mortality has reignited scrutiny of prescribing practices by law enforcement, regulatory agencies, and state medical boards. At the same time, the predominant 4D model of misprescribers is outdated and insufficient; it groups physician misprescribers as dated, duped, disabled, or dishonest. The weaknesses and inaccuracies of the 4D model are explored, along with the serious consequences of its application. This Article calls for development of an evidence base in this area and suggests an alternate model of misprescribers, the 3C model, which more accurately characterizes misprescribers as careless, corrupt, or compromised by impairment.

I.   INTRODUCTION
II.  DEFINING MISPRESCRIBING AMIDST INCOMPLETE DATA AND AN
     INACCURATE CONCEPTUAL FRAMEWORK
     A. Incomplete Data
     B. A Harmful Model: 4Ds
        1. The Problem with Duped
        2. The Lie Detection Fallacy, Law Enforcement, and
           Physician Responses
III. REGULATION OF MEDICAL PRACTICE AND PRESCRIBING
     A. Medical Malpractice
     B. State Boards of Medicine
     C. Additional Regulation of Physician Prescribing
        1. The Food and Drug Administration
        2. The Drug Enforcement Agency and the Controlled Substances
           Act
        3. Increased Opioid Prescribing Scrutiny
IV.  CARELESS, CORRUPT, AND COMPROMISED PHYSICIAN
     MISPRESCRIBERS
     A. Careless Physicians
     B. Corrupt Physicians
     C. Compromised by Impairment
V.   CONCLUSION: A MODEST PROPOSAL AND IMPLICATIONS FOR
     RESEARCH
TABLE 1. THE 3C MODEL OF PHYSICIAN MISPRESCRIBERS WITH
DESCRIPTION AND PROPOSED SANCTIONS

I. INTRODUCTION

"Opioids play a unique role in society. They are widely feared compounds, which are associated with abuse, addiction and the dire consequences of diversion; they are also essential medications, the most effective drugs for the relief of pain and suffering. " (1)

Physicians are understandably conflicted about how, when, and whether to prescribe opioids. On the one hand, relief from suffering is a primary obligation of physicians, and pain remains undertreated after decades of improvement efforts. (2) The inadequate treatment of pain was the subject of significant clinical and policy efforts in the 1990s; (3) among those efforts were the increased use of opioids for acute pain and the use of long-term opioid therapy for patients with chronic pain. (4) Although opioid prescriptions are only one aspect of effective pain treatment, the failure to utilize opioids in appropriate circumstances causes suffering and creates a barrier to effective pain care. (5) According to Cheatle and Savage, "[o]ne of the barriers to effective pain management across the spectrum of pain conditions ... is the clinician's fear of prescribing opioids beyond that merited by the actual risks." (6) Efforts in 1990s to lessen barriers to appropriate opioid use did result in decreased suffering for some patients. (7)

On the other hand, medicine's embrace of expanded opioid use and the influence by pharmaceutical companies on that use (8) has had unintended consequences. Though many patients experience a newfound relief from suffering, (9) the nonmedical use of opioids has also increased substantially. (10) A small percentage of patients with underlying vulnerabilities to substance use disorders ("SUDs") may develop opioid use disorders from prescriptions to treat pain, while other individuals with SUDs (11) find a new drug of choice in diverted prescription opioids. (12) In 2010 alone, an estimated 16,000 individuals died from nonmedical use of prescription opioids, typically in combination with other drugs or alcohol. (13) These deaths have garnered significant public attention. (14)

In limited instances, physicians may behave negligently or worse in prescribing opioids. Although any inappropriate prescription can have negative consequences for both physicians and their patients, those consequences are significant in the case of opioids. (15) Opioid use disorders ("OUDs"), a subset of SUDs, are now the "second most common drug use disorder[]" in the United States, and prevalence has increased over the last two decades. (16) In addition, the majority of individuals with OUDs do not receive treatment, despite the significant psychiatric co-morbidities and risk of overdose death. (17) OUDs also carry societal and economic costs. (18) Because opioids are regulated, prescription-only medications, dispensers, distributors, and physicians are all facing scrutiny. (19) Although most of those with OUDs and those who suffer opioid related overdoses (OROs) do not obtain their opioids directly from their physician, some do. (20) Except for the opioids diverted in the supply chain before reaching dispensers, borrowed or stolen opioids originate as valid prescriptions. (21) Additionally, about twenty-seven percent of long-standing opioid abusers receive these drugs directly by prescription. (22) Therefore, prescribing and patient education practices play a role in the availability of opioids for misuse (23) and the harms that flow from OUDs. (24)

Physicians bear responsibility for careful and conscientious prescribing, which includes patient assessment, communication, and education. (25) In practice, that responsibility may be heightened in the case of opioids. Physicians can face serious legal sanctions for inappropriate prescribing, including malpractice liability, medical board discipline, and criminal convictions. (26)

Physicians have an obligation to treat pain, and opioids remain one of the most broadly effective medications for many types of pain; (27) at the same time, physicians do not want to face legal entanglements related to prescribing opioids. In order to avoid the latter, it is important to understand when and why physicians face sanction for improperly prescribing opioids. Yet the reasons are currently confounding because of the paucity of trustworthy, current data, and the heterogeneity and inaccuracy of categories in the dominant "4D model" meant to explain such cases. Physician involvement ranges from clearly criminal behavior (28) (innocuously referred to as "dishonest") to falling victim to patient dishonesty ("duped"). (29)

Policy makers continue to rely on the 4D Model, which was developed over thirty years ago, to group physicians who abuse their prescribing privileges or disregard their professional obligations completely (misprescribers) into four categories: dated, duped, dishonest, or disabled. (30) The categorization, originally intended both to describe misprescriber characteristics and guide appropriate discipline, (31) was subject to calls for refinement as early as 1990. (32) The descriptors are both over-inclusive and under-inclusive, leading to unpredictable and inconsistent enforcement. The duped category reflects patients' behavior, an inappropriate and misleading focus for regulatory oversight. Nonetheless, in its original form, the 4D Model continues to guide regulators as well as law enforcement.A better model is urgently needed; one that consistently focuses on a physician's professional behaviors, not the patient's, and describes a physician's choices, not his length of time in practice. Medicine is increasingly adapting to the complexity of opioid use, as well as the models of care needed for patients with multiple, complex chronic conditions, such as those involving both pain and SUD. These already nuanced clinical choices should not be burdened with fear of unwarranted investigation. Such fear can exacerbate stigmatization and encourage patient avoidance of care. (34) Instead, a model is needed that allows physicians to prioritize each patient's well-being. (35) At the same time, the model must more accurately describe behaviors that rise to the level of misprescribing, thus guiding appropriate investigation and sanction.

This Article provides an overview of the regulation of opioid prescribing, the limitations and possible harms associated with the American Medical Association's (AMA) current 4D misprescribing framework, and draws attention to the need for ongoing research. The Article begins in Part II by reviewing the fundamental problems--the paucity of data and the limitations of the 4D model. Part III examines the legal regulation of medical practice and prescribing, and Part IV reviews cases in which physicians have been criminally prosecuted, presenting them within a 3C framework (Corrupt, Compromised by impairment, and Careless), which focuses on physician-related reasons for the misprescribing. Finally, this Article suggests that the 3C Model better reflects the causes of legal action and better guides the responses of regulators and law enforcement than the current 4D model because the 3C model focuses exclusively on the role of physicians in misprescribing.

II. DEFINING MISPRESCRIBING AMIDST INCOMPLETE DATA AND AN INACCURATE CONCEPTUAL FRAMEWORK

When physicians act and prescribe with integrity they enhance trust in the profession and allow for social disclosures and interactions that improve care. (36) In the context of opioid prescribing, courts have recognized that integrity may be challenged by uncertainty about which decisions most decrease suffering and promote well-being, especially when there is considerable pressure to act out of self-protection. (37) Nonetheless, "[p]hysicians are responsible for ... 'providing the time, skill, and knowledge'" required for careful prescribing. (38)

The label "misprescribing" should refer to a set of prescribing behaviors that demonstrably depart from the standard of care, such as issuing prescriptions without appropriate medical purposes or in inappropriate dosages or quantities given the characteristics of the patient to whom they are prescribed. Unfortunately, misprescribing is sometimes distorted and misused to describe an unfortunate outcome, such as when a patient who intends to sell his or her prescription successfully fools a physician or when a patient has an unexpected adverse reaction. (39) The term misprescribing should be clear and should not include a physician who might follow standards of care and nevertheless write a prescription that does not serve a patient well for any number of reasons, such as an unknown allergic reactions, gene-drug interactions, or misinformation provided by a patient.

A. Incomplete Data

"It is one thing to cite statistics supporting the observation that opioid-related deaths have risen drastically in recent years. It is quite another matter to obtain and interpret specifics of how the deaths occurred so as to inform clinical practice going forward." (40)

The information available about physician misprescribing is in small supply. Existing studies tend to look at a broad set of behaviors that result in sanction, rather than just focusing on prescribing. (41) Most confine their studies to cases from one state, (42) from particular oversight boards, (43) or from specific types of sanctions (44) Even these tend to cover data before 2007 45 Results from those studies indicate that those sanctioned disproportionately are older. (46) male, (47) lack board certification, (48) and work in general practice, family practice, or specialize in psychiatry. (49)

A few studies focus specifically on prescribing. Goldenbaum and colleagues studied opioid misprescribing and found the physician characteristics of those studied were similar to the more general studies of sanctioned physicians: older, male, non-board certified, general or family practitioners were more likely to face sanction. (50) Current work by DuBois and colleagues on misprescribing of controlled substances (primarily opioids) found similar patterns." Rather than studying physician demographics, Rich and Webster looked at underlying behavior patterns by analyzing medical records in malpractice opioid overdose cases from 2005 to 2009. (52) They attributed the cause of overdose to physician error in seventy-five percent of the cases. (53) Those cases of physician error revealed a pattern of actions below the standard of care, including multiple medication errors in terms of dosing and conversion of doses between drugs. (54) None of the cases studied included physicians engaged in the criminal enterprise, but they did reveal concerns about careless prescribing habits. (55)

In short, more misprescribing data are needed, including data from the investigation stage through to the sanction stage. Current data do not provide a comprehensive picture of the problem or reflect the increased enforcement and regulatory efforts of the last ten years. (56)

B. A Harmful Model: 4Ds

"Language is more than just a vehicle for ideas: it shapes ideas--and the practices that follow from them." (57)

Decades ago, the AMA endorsed the 4D model to describe physicians who overprescribe. The four Ds are (1) dated, (2) duped, (3) disabled, and (4) dishonest. (58) The model grew out of addiction medicine experts' work on physician prescribing practices courses in the late 1970s. (59) David E. Smith described the development of the 4D model as an evolution from work with physicians on disciplinary probation and other misprescribers. (60) The model was included in a White House-sponsored conference on prescription drug abuse and later endorsed by the AMA. (61)

Under the 4D model, a dated physician is described as "out of date regarding knowledge of pharmacology and the different diagnosis and management of chronic pain...." (62) A duped physician is "one who inadvertently supplies drugs to a drug abuser because the physician has been deceived by a drug abuser posing as a patient." (63) Disabled physicians are impaired because of an SUD or other medical or psychiatric disability, (64) which may lead them to divert prescriptions for their personal use or to exhibit judgment so poor as to lead to patient harm. Finally, dishonest physicians are those who use their access to prescribing for personal gain (financial or otherwise). (65)

The problem with the model, over time, is that the descriptors are not accurately aligned with the realities of opioid misprescribing, and accuracy matters when a framework is used to guide the adjudication of cases. While the framework suffers from several problems (e.g., "dishonest" is far too gentle a descriptor for the physicians who embrace a criminal identity and "dated" may be ageist), this Article focuses on the problem created by the "duped" category because it is the most severe.

1. The Problem with Duped

"Good doctors have been and will continue to be deceived by patients, and undoubtedly there will be a few bad doctors who attempt to deceive others. In the end, however, we must not lose sight of the millions of patients who are suffering.... " (66)

The language of duped may cause unreasonable expectations for physicians from law enforcement, regulators, and even the medical field. A false narrative pervades medicine regarding physicians' abilities to spot deceptive patients. Longo and colleagues suggest that physicians who try to help patients in pain and foster trust are "vulnerable to a manipulative patient." (67) But this presumes that a less "therapeutic" physician would not be fooled. There is no evidence to support this assumption. Twenty-five years ago, Wesson and Smith understood this, explaining "[t]he term 'duped' is not always appropriate in these situations because it implies the physicians are careless, easily deceived, or foolish. It has an implied converse: that careful, competent physicians would ... recognize[] the deception." (68) Karen Drummond explains this as the cultural narrative of the wily "drug-seeking" patient and naive, "fooled" physicians: "[a]n unspoken clinical skill one is supposed to gain in the course of training is the ability to recognize 'drug seeking behavior' in order to not be 'fooled' by the drug seeking patient." (69) She describes how this fallacy has taken hold of the culture through the media, such as "medical dramas" that depict experienced doctors and street wise nurses shaking their heads at "a bumbling new intern ... tricked by a 'frequent flier' patient." (70)

This fallacy pervades law enforcement attitudes as well. Testimony and press releases often focus on times when a physician prescribed medication for an undercover police officer posing as a patient. (71) Jung and Reidenberg also noted this fact, with physician deception alone offered as evidence of misprescribing. (72) Zeigler has pointed out that those media reports negatively influence cultural attitudes and prescribing behavior. (73)

Labeling physicians as misprescribers for merely being fooled is improper. While this has been acknowledged in the literature, (74) physicians have inappropriately faced sanctions simply for being fooled. (75) In fact, recent research found that even after training, people could not detect real versus faked pain more than fifty-five percent of the time. (76) Detection of patients with "fake" complaints by physicians may be even more difficult because of the presumption that patients come to them because of problems, sometimes called the "truth bias." (77) This is also demonstrated by physicians' poor rates of detection of actors or standardized patients in other studies. (78) Being fooled is no measure of malpractice, and certainly no measure of criminal behavior. (79) Holding physicians accountable for being fooled also resurrects paternalistic notions of wise physicians directing naive patients. (80) Any physician who prescribes opioids is vulnerable to being duped by a deceptive patient; there is no degree of conscientiousness that can prevent it. (81) There is also no justification for physicians to abandon their "truth bias" with patients; it is part of the relational trust the underscores a successful physician-patient relationship. In the context of pain, physicians may be motivated to abandon their truth bias out of fear of sanction for being duped. (82) This fear may lead some to avoid opioids altogether, a position that is inconsistent with physicians' obligations to the patients. Jung and Reidenberg describe the implications of the fear of deception: "[b]oth deception and fear of deception have consequences. Patients can get ... insufficient medical care when the doctor fears deception (disbelieving reports of pain when it exists). These consequences affect both the individual patient and society." (83)

2. The Lie Detection Fallacy, Law Enforcement, and Physician Responses

Law enforcement's expectations that physicians will detect deception are unjustified but unsurprising in a field infected with overconfidence. Research with law enforcement demonstrates consistent unwarranted overconfidence by officers in their own lie detection abilities. (84) Part of this overconfidence probably stems from the backward looking nature of investigation and the bias that it engenders. Others have identified long-standing training techniques for law enforcement that focus on nonverbal cues and other behaviors that have proven empirically false. (85) Moreover, research has shown that exposure to these training techniques exacerbates overconfidence without improving the actual ability to detect deception. (86) Scores of research establishes the rate of lie detection at about fifty-four percent--a whisper above chance--regardless of training or confidence. (87) In fact, some research indicates that college students may even be better at detecting lies than police investigators. (88)

Actors in the legal system are immersed in a culture saturated with lie detection mythology. (89) According to the Supreme Court, "[a] fundamental premise of our criminal trial system is that 'the jury is the lie detector.'" (90) Juries are expected to determine, at a rate better than chance, which witnesses are trustworthy by virtue of their "natural intelligence and their practical knowledge ... " (91) Given the pervasiveness of the lie detection fallacy in law, it is not surprising that law enforcement and adjudicators are willing to assign blame to physicians who are deceived by patients despite due care.

Worse yet for physicians, recent research has found a connection between emotional intelligence and susceptibility to deception. (92) Baker and colleagues found that empathy of emotionally intelligent individuals might impair their ability to discriminate between genuine and deceptive actors, thus making them more susceptible to deception than the average person. (93) This has serious implications for the many physicians conflicted by simultaneous obligations to trust their patients and to relieve suffering without further contributing to drug diversion and the harms of SUD. The medical literature is replete with evidence of the clinical value of emotional intelligence and its positive effect on physician patient relationships, patient outcomes, and physician satisfaction, (94) as well as its contribution to effective medical leadership. (95) In the context of pain, emotional intelligence and empathy are associated with the successful management of patients with multiple chronic problems, such as chronic pain. (96) Further, many programs exist to actually enhance emotional empathy in medicine to improve patient care. (97) What then, is a physician to do? Asking physicians to set aside the skills that facilitate effective patient care in an effort to prevent the occasional deceptive patient is contrary to the ends of medicine. A recent consensus statement by pharmacists on prescribing and dispensing controlled substances recommends trusting patients:

   [T]he best clinical approach in most circumstances is to assume the
   patient is reporting a true experience. Accepting a patient's
   complaint of pain as valid does not require clinical identification
   of a physical cause, or demand the initiation of a specific
   treatment. It does, however, provide the foundation for assessment
   and the basis for developing an effective patient-physician
   dialogue.... (98)

This position recognizes that there are disproportionate harms to encouraging suspicion of patients. The fear of deceit alone can compromise physician trust in patients, and that fear likely already contributes to avoidance of certain patient groups. Maia Szalavitz describes the tension this way: "[d]octors who would overlook a patient's lies about, say, diet and exercise instead become personally affronted about painkiller misuse. It's hardly surprising. Being fooled in this way can have severe legal consequences for the doctor." (99) There have been several notable cases in which evidence of being fooled was the basis for arrest even though contextual information reveals a typical interaction. (100) While there is no way to completely eliminate the risk of a false or erroneous arrest, (101) the use of the word "duped" may contribute to an increased risk of scrutiny based on being fooled. Those situations in which physicians are fooled because of their own carelessness are distinct and should be characterized in a way that reflects this distinction and level of culpability as well as the appropriate legal sanctions.

The language used to model misprescribing must not perpetuate this lie detection fallacy: "duped" as one of the 4Ds is not only inaccurate, it is harmful to physicians and to patients. Michael J. Brennan put it this way: "[w]e know we can not be 100% right all the time. Without an understanding of how right must we be, or how wrong are we allowed to be ... we will be floundering about with the issue of physician prosecution or the perception of such, forever." (102)

III. REGULATION OF MEDICAL PRACTICE AND PRESCRIBING

Law regulates medical practice both directly and indirectly. (103) Regulation of physician practice generally "orients itself around the few bad apples ... rules and enforcement efforts are targeted at finding, punishing, and deterring bad behavior on the part of a minority of the physician population." (104) Yet, the investigation alone is burdensome and a driver of physician behavior: the "penalties of the process" produce physician avoidance of clinical activities that may place them in reach of investigation. (105) Physicians may find themselves embroiled in multiple legal and quasi-legal proceedings relating to the same prescribing events. (106) For example, physicians may face medical malpractice liability; medical board discipline ranging from reprimand to revocation of their medical license(s); exclusion from federal programs; (107) criminal charges ranging from misdemeanors to felonies; federal and state fraud charges for claims for services and prescriptions paid by the government on behalf of patients;108 exclusion from participation in state programs; (109) breach of contract actions from private third party insurance providers; hospital peer review; (110) and other proceedings by organizations to strip the physician of membership or special status. (111) An investigation alone can be devastating and a finding of liability can trigger a cascade of consequences that make it impossible to practice medicine. The most common actions related to misprescribing are reviewed below.

A. MEDICAL MALPRACTICE

The general public is most apt to think of medical malpractice as a regulator of physician conduct although it is, at best, an extreme indicator of quality of care. (112) In reality, malpractice claims do not correlate well with the quality of physician practices; (113) factors such as poor outcomes and the degree to which the patient likes the physician are more powerful predictors of malpractice suits. (114) Incompetent but likable physicians may avoid the consequences of malpractice for some time. A malpractice action not dismissed in the early stages can be devastating for the provider's reputation and reserves. This creates perverse incentives to avoid malpractice actions, which may lead to overtreatment. (115) With regard to prescription opioids, however, there have also been a handful of cases in which physicians faced liability for undertreating pain. (116)

The outcome of malpractice cases often rests on the standard of care, which is a measure of "prevailing custom, with some substantial tolerance for 'respectable minority' views, [and] has been the gold standard for scrutinizing physician practice and treatment decisions in the malpractice context." (117) The standard of care is one of the most malleable elements of malpractice cases because it is not a fixed concept; (118) there are usually multiple reasonable and appropriate standards, or '"right ways' of doing things for a patient." (119) For example, courts have held that failing to follow every recommendation of a state medical board prescribing policy is insufficient to establish a failure to meet the standard of care. (120) A number of factors--such as exam, dosing, patient education, and referrals--are relevant to a determination of breach in prescribing cases; they are considered in the context of the patient's particular history and presentation. (121) At the same time, one material and sufficient deviation from the standard of care may create liability. (122) While malpractice might apply to certain prescribing practices, without a pattern or other evidence, it is a poor barometer of competency. (123)

B. STATE BOARDS OF MEDICINE

"Physicians should be aware that the legal system views medical licensure as an exclusive privilege. As such, physicians are held to a higher standard of moral and personal conduct than the general population ... actions that reflect poor judgment, flawed character, and sub-standard decision-making may trigger state medical board sanctions." (124)

Medical practice is also regulated by state medical boards ("SMBs")--regulatory agencies created by state medical practice act legislation. (125) The Federation of State Medical Boards' Model Practice Act describes the purpose and function of SMBs:

   The practice of medicine is a privilege granted by the people
   acting through their elected representatives [1)] [i]n the
   interests of public health, safety, and welfare, and [2)] to
   protect the public from the unprofessional, improper, incompetent,
   unlawful, fraudulent and/or deceptive practice of medicine, it is
   necessary for the government to provide laws and regulations to
   govern the granting and subsequent use of the privilege to
   practice
medicine. (126)

Thus, SMBs' primary obligation is protection of health and safety of citizens through oversight of medical practice. (127) Vulnerable populations are especially in need of SMB protection. (128) SMBs regulate through a host of educational, practice, and fitness standards to ensure the basic competence physicians. (129) Although reactive by nature, (130) SMBs "have the statutory duty and authority to penalize or remove from practice physicians who provide substandard care." (131) They also have considerable latitude to investigate, adjudicate, and sanction physician behavior; sanctions can range from a reprimand to complete revocation of a license to practice. (132) Although the research is limited, factors such as board certification, gender, country of training, and type of aberrant activity are associated with the likelihood of disciplinary proceedings. (133)

A substantial number of SMB actions involve misuse and misprescribing of controlled substances, including opioid misprescribing. …

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